Ocular Therapeutix™ Begins Enrollment in Third Phase 3 Clinical Trial for DEXTENZA™ for the Treatment of Post-Surgical Ocular Inflammation and Pain

BEDFORD, Mass.--(BUSINESS WIRE)--Oct. 14, 2015--
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye, today announced the enrollment
of the first patients in a third Phase 3 clinical trial for DEXTENZATM
(sustained release dexamethasone) 0.4mg Intracanalicular Depot, for the
treatment of post-surgical ocular inflammation and pain.

Based on the results of the Company’s two previously completed Phase 3
clinical trials and following a Pre-NDA Clinical meeting with the U.S.
Food and Drug Administration (FDA) in April 2015, the Company recently
submitted a New Drug Application (NDA) to the FDA for DEXTENZATM
(sustained release dexamethasone) 0.4mg Intracanalicular Depot, for the
treatment of ocular pain following ophthalmic surgery. The Company
intends to submit a supplement to the NDA for the treatment of
post-surgical inflammation as part of its label expansion strategy for
DEXTENZA if it obtains favorable results from this third Phase 3
clinical trial and subject to receiving approval of the pain indication
pursuant to the initial NDA.

“This is an important step for Ocular as we continue to execute on our
label expansion strategy for DEXTENZA and we look forward to offering
patients this innovative alternative to steroid eye drop therapy,” said
Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman.

This prospective, multicenter, randomized, parallel-arm, double-masked,
vehicle-controlled study is enrolling 436 patients undergoing clear
corneal cataract surgery at 20 sites throughout the United States.
Following surgery, patients will be randomized to either DEXTENZA or a
placebo vehicle. Primary endpoints are absence of anterior chamber cells
at day 14 and reduction of pain at day 8. Based on the learnings from
the two previously conducted Phase 3 clinical trials and following a
Pre-NDA Clinical meeting with the FDA, the Company has designed this
trial to include key modifications, such as:

1:1 patient randomization of treatment and placebo groups instead of a
2:1 randomization;

Exclusion of patients who are being treated with high dosage levels of
oral nonsteroidal anti-inflammatory drugs, or NSAIDs; and

Improvement of the training and guidance to the on-site clinical
investigators regarding adherence to study protocols, including the
appropriate use of rescue medications.

The Company anticipates that top-line efficacy results from this trial
will be available in late 2016.

About DEXTENZATM

DEXTENZA (sustained release dexamethasone) 0.4 mg Intracanalicular Depot
is a product candidate placed through the punctum, a natural opening in
the eyelid, into the canaliculus and delivers dexamethasone to the
ocular surface for four weeks. Following treatment, DEXTENZA resorbs and
exits the nasolacrimal system without need for removal. To capitalize on
the broader opportunity for the sustained delivery of corticosteroids to
the front of the eye, the Company is pursuing multiple indications for
DEXTENZA.

Earlier this year, Ocular Therapeutix announced results from its two
completed Phase 3 clinical trials of DEXTENZA for the treatment of
ocular inflammation and pain following ophthalmic surgery. The Company
recently submitted an NDA to the FDA for ocular pain following
ophthalmic surgery and has initiated the third Phase 3 clinical trial
for ocular inflammation and pain. The Company recently completed
enrollment in a Phase 3 clinical trial of DEXTENZA for the treatment of
allergic conjunctivitis and expects to report topline efficacy data from
this trial in the fourth quarter of 2015. The Company has also completed
patient enrollment in an exploratory Phase 2 clinical trial of DEXTENZA
for the treatment of inflammatory dry eye and expects to report topline
efficacy data from this trial in the fourth quarter of 2015.

About Ocular Inflammation and Pain Following Ophthalmic Surgery

Ocular pain and inflammation are common side effects following
ophthalmic surgery. Physicians prescribe anti-inflammatory drugs, such
as corticosteroids, as the standard of care. If left untreated,
inflammation of the eye may result in further ocular complications,
including scarring and vision loss. Approximately 5.3 million ocular
surgeries were performed in the United States in 2014.

About Ocular Therapeutix

Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye using its proprietary hydrogel
platform technology. Ocular Therapeutix's lead product candidates are in
Phase 3 clinical development for post-surgical ocular inflammation and
pain and allergic conjunctivitis, and Phase 2 clinical development for
glaucoma and inflammatory dry eye disease. The Company is also
evaluating sustained-release injectable anti-VEGF drug depots for
back-of-the-eye diseases. Ocular Therapeutix's first product, ReSure® Sealant,
is FDA-approved to seal corneal incisions following cataract surgery.

Forward Looking Statements

Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development of the Company’s product candidates, such as the Company’s
plans for regulatory submissions and the design, initiation and conduct
of a third clinical trial of DEXTENZATMfor
post-surgical inflammation and pain, the ongoing development of the
Company’s sustained release hydrogel depot technology, the timing and
conduct of the Company’s Phase 2b clinical trial of OTX-TP for the
treatment of glaucoma and ocular hypertension, the Company’s Phase 3
clinical trials of DEXTENZA for allergic conjunctivitis and the
Company’s Phase 2 clinical trial of OTX-DP for the treatment of
inflammatory dry eye disease, the advancement of the Company's other
product candidates and other statements containing the words
"anticipate," "believe," "estimate," "expect," "intend", "goal," "may",
"might," "plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions,
constitute forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements as a
result of various important factors. Such forward-looking statements
involve substantial risks and uncertainties that could cause the
Company’s clinical development programs, future results, performance or
achievements to differ significantly from those expressed or implied by
the forward-looking statements. Such risks and uncertainties include,
among others, those related to the timing and costs involved in
commercializing ReSure® Sealant, the initiation
and conduct of clinical trials, availability of data from clinical
trials and expectations for regulatory submissions and approvals, the
Company’s scientific approach and general development progress, the
availability or commercial potential of the Company’s product
candidates, the sufficiency of cash resources and need for additional
financing or other actions and other factors discussed in the “Risk
Factors” section contained in the Company’s quarterly and annual reports
on file with the Securities and Exchange Commission. In addition, the
forward-looking statements included in this press release represent the
Company’s views as of the date of this release. The Company anticipates
that subsequent events and developments will cause the Company’s views
to change. However, while the Company may elect to update these
forward-looking statements at some point in the future, the Company
specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing the Company’s views
as of any date subsequent to the date of this release.

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